QMS structure

Procedures for ISO 13485

The image below shows a visual overview of the procedures (tier 1 and 2) and their interactions in a QMS based on ISO 13485.

(Requirement 4.2.2c Quality Manual: “a description of the interaction between the processes of the quality management system“).

Click on the image for the complete overview

NOTE: The structure shows how my QMS for ISO 13485 is organized. This is not the only possible way: the structure of your QMS may look different, but that doesn’t mean it’s false!

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